U.S. FDA nod for Mylan GmbH’s Ogivri (trastuzumab-dkst) for the treatment of breast and stomach cancer
U.S. FDA (Food and Drug Administration) announced that it granted final approval to Mylan GmbH’s Ogivri (trastuzumab-dkst) for the treatment of breast and stomach cancer
Company: Mylan GmbH
Brand Name: Ogivri trastuzumab-dkst
Dosage Form: Tablets
Generic name: trastuzumab-dkst
General information about Ogivri (trastuzumab-dkst)
Ogivri (trastuzumab-dkst) is a HER2/neu receptor antagonist biosimilar to Herceptin indicated for the treatment of HER2-overexpressing breast cancer and the treatment of HER2-overexpressing stomach cancer.
It is used for the treatment of patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors overexpress the HER2 gene (HER2+). Ogivri is the first biosimilar approved in the U.S. for the treatment of breast cancer or stomach cancer and the second biosimilar approved in the U.S. for the treatment of cancer.